Home GUDID 07445161002136 Motiva® SmoothSilk® Round Breast Implant
Primary DI 07445161002136
Brand Motiva® SmoothSilk® Round Breast Implant
Company Establishment Labs S.A.
Model RSF-425+
Catalog number RSF-425+
Device description Motiva® SmoothSilk® Round Breast ImplantRound Breast Implant - Full 425 cc
Published 2024-10-04
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled General, Plastic Surgery 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07445161002136 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07445161002136 07445161002136 7445161002136
GMDN Terms# Term, Definition table Term Definition Silicone gel-filled breast implant, smooth-surface An implantable device designed to reconstruct or augment the breast that is composed of a silicone rubber shell, made of polysiloxane(s), with a single lumen filled with a fixed amount of silicone gel; the shell surface is smooth. The implant may vary in shape, profile, volume and shell thickness.
Sterilization Methods# Method table Method Dry Heat Sterilization
Regulatory Flags# DUNS number 853166098 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Expiration date on label true No natural rubber latex true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07445161009579 Motiva® Inflatable Balloon MIB-0090 MIB-0090 2025-06-06 07445161009586 Motiva® Inflatable Balloon MIB-0100 MIB-0100 2025-06-06 07445161027290 Motiva® Channel Separator MCS-20US MCS-20US 2025-06-06 07445161009494 Motiva® Inflatable Balloon MIB-0080 MIB-0080 2025-06-06 07445161001702 Motiva® SmoothSilk® Round Breast Implant RSM-245+ RSM-245+ 2024-10-04 07445161001719 Motiva® SmoothSilk® Round Breast Implant RSM-260+ RSM-260+ 2024-10-04 07445161001726 Motiva® SmoothSilk® Round Breast Implant RSM-275+ RSM-275+ 2024-10-04 07445161001733 Motiva® SmoothSilk® Round Breast Implant RSM-290+ RSM-290+ 2024-10-04 07445161001740 Motiva® SmoothSilk® Round Breast Implant RSM-310+ RSM-310+ 2024-10-04 07445161001757 Motiva® SmoothSilk® Round Breast Implant RSM-360+ RSM-360+ 2024-10-04 07445161001764 Motiva® SmoothSilk® Round Breast Implant RSM-400+ RSM-400+ 2024-10-04 07445161001849 Motiva® SmoothSilk® Round Breast Implant RSD-205+ RSD-205+ 2024-10-04 07445161001856 Motiva® SmoothSilk® Round Breast Implant RSD-215+ RSD-215+ 2024-10-04 07445161001863 Motiva® SmoothSilk® Round Breast Implant RSD-230+ RSD-230+ 2024-10-04 07445161001870 Motiva® SmoothSilk® Round Breast Implant RSD-245+ RSD-245+ 2024-10-04 07445161001887 Motiva® SmoothSilk® Round Breast Implant RSD-265+ RSD-265+ 2024-10-04 07445161001894 Motiva® SmoothSilk® Round Breast Implant RSD-285+ RSD-285+ 2024-10-04 07445161001900 Motiva® SmoothSilk® Round Breast Implant RSD-300+ RSD-300+ 2024-10-04 07445161001917 Motiva® SmoothSilk® Round Breast Implant RSD-320+ RSD-320+ 2024-10-04 07445161001924 Motiva® SmoothSilk® Round Breast Implant RSD-340+ RSD-340+ 2024-10-04
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07445161001702 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001719 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001726 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001733 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001740 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001757 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001764 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001849 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001856 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001863 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001870 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001887 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001894 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001900 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001917 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001924 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001931 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001948 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001955 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001962 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161001979 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161002051 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161002068 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161002075 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161002082 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161002099 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161002105 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161002112 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161002129 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04 07445161002143 Motiva® SmoothSilk® Round Breast Implant Establishment Labs S.A. FTR 2024-10-04